Effect of Structured Training Program in Diabetic Patients

Effect of Structured Training Program on Functional Abilities in Patients With Diabetic Neuropathy

Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: Structured Exercise Program; Other: Non structured exercise program

Detailed Description

The goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with DPN, despite the existence of various individualized exercise programs designed for DPN patients. The main questions this study aims to answer is:

What is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with DPN on pain, sensory symptoms, balance, vibration sense and Quality of life?

Group 1:

Patients in group 1 will receive a structured exercise program.

Group 2:

Patients in group 2 will receive a non-structured exercise program. This group will allow us to compare the effects of a structured and a non-structured exercise program.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Subhasish Chatterjee, PhD; Phone Number: 8708660994; Email: subhasishphysio@mmumullana.org
• Study Contact Backup: Name: Khushboo Kumari, BPT (MPT); Phone Number: 08718089830; Email: physio.khushboo11@gmail.com

Study Locations

• India
  • Haryana
    • Ambala, Haryana, India, 133207
      • Recruiting
      • MMIPR
      • Contact: Subhashish Chatterjee, MPT(NEURO); Phone Number: +918950037407; Email: subhasishphysio@gmail.com
      • Principal Investigator: Subhashish Chatterjee, MPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diabetes mellitus with moderate to severe DPN
• Subjects of both gender
• Age from 40 to 70 years
• Independent walking
• MNSI score more than 2 out of 13

Exclusion Criteria:

• Presence of an active planter ulcer
• History of surgery during intervention period
• Neurological diseases other than DPN

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group-1 (Structured Exercise Program); Patients undergo structured exercise sessions lasting 30 minutes, encompassing activities such as range of motion, flexibility exercises, strength training, balance exercises, and aerobic exercises, with designated intervals between each session.	Other: Structured Exercise Program; 30 minutes of structured exercise programs
Other: Group-2 (Non-Structured Exercise Program); Patients are provided with a simple exercise routine that lacks a structured format.	Other: Non structured exercise program; Non structured exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan neuropathy screening instrument (MNSI)	The scale consists of two parts: the first part involves a patient history assessment, while the second part focuses on physical examination. This scale is considered both reliable and practical for evaluating the severity of neuropathy. If the patient's score increases, it indicates a higher severity of the disease, whereas if the score decreases, it suggests a lower severity.	The measurement will be taken during the baseline assessment and again after the completion of treatment.
Biothesiometer	This objective measure is utilized to assess the vibratory pressure threshold in affected areas. It possesses the capability to detect various frequencies for vibratory pressure threshold assessment. It is regarded as a practical tool for evaluating both superficial and vibratory sensations. If there is an increased perception of frequency, it indicates that the vibratory pressure threshold is more severely affected.	The measurement will be taken during the baseline assessment and again after the completion of treatment.
NeuroQoL	The Neuropathy-and Foot-Ulcer Specific Quality of Life Instrument is designed as a Likert scale and serves as a reliable method for assessing quality of life related to neuropathy. If the scoring indicates a higher value, it suggests that the disease is more severe.	The measurement will be taken during the baseline assessment and again after the completion of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NPRS	The Numeric Pain Rating Scale, ranging from 0 to 10, is employed as a subjective assessment tool to measure an individual's pain perception. In general, higher scores on the scale indicate a greater severity of pain linked to the disease.	The measurement will be taken during the baseline assessment and again after the completion of treatment.

Collaborators and Investigators

• Sponsor: Maharishi Markendeswar University (Deemed to be University)
• Investigators: Principal Investigator: Khushboo Kumari, BPT, (MPT), Maharishi Markandeshwar Instirtute of Physiotherapy and Rehabilitation, Ambala, Haryana, 133207

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Actual): February 8, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: IEC-2418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No